Acura Pharmaceuticals to Develop Improved NEXAFED(R)

Acura Pharmaceuticals to Develop Improved NEXAFED(R) 
IMPEDE(R) 2.0 Reduces One-Pot Methamphetamine Yield to Near Zero 
PALATINE, IL -- (Marketwired) -- 07/15/13 --  Acura Pharmaceuticals,
Inc. (NASDAQ: ACUR) today announced a second generation prototype
formulation of its methamphetamine-resistant IMPEDE technology with
pseudoephedrine hydrochloride yielded no measurable amount of crystal
meth (the street name for the illicit drug methamphetamine
hydrochloride) when processed in the direct conversion or one-pot
method. Acura intends to immediately commence development of an
upgraded NEXAFED [pseudoephedrine hydrochloride] Tablet using IMPEDE
2.0. NEXAFED is currently distributed through national and regional
drug wholesalers to chain and independent drugstores nationwide. For
more information about NEXAFED, visit JOIN-FIGHT.COM. 
IMPEDE 2.0 was created through the addition of two new inactive
pharmaceutical ingredients to Acura's existing IMPEDE technology.
IMPEDE 2.0 was tested by an outside laboratory using an optimized,
high yield direct conversion test method that is designed to
replicate the direct conversion, or one-pot, process commonly
utilized by clandestine methamphetamine laboratories. IMPEDE 2.0
yielded no measurable amount of methamphetamine in its initial
testing compared to an approximate 38% yield with the older IMPEDE
technology. Acura intends to validate these results, and perform its
battery of extraction tests on the reformulated NEXAFED tablets. 
"We are excited to advance our IMPEDE technology demonstrating its
adaptability to the ever changing meth production problem," said
Robert B. Jones, president and chief executive officer of Acura
Pharmaceuticals. "NEXAFED is the only meth-resistant pseudoephedrine
product on the market that meets the Food and Drug Administration's
bioequivalence standards for demonstrated effectiveness. If NEXAFED
with IMPEDE 2.0 can also meet that standard, we believe we will have
a meth-resistant pseudoephedrine product that delivers unmatched
performance." 
About Methamphetamine Abuse
 Methamphetamine is a highly addictive
illicit drug used non-medically by an estimated 13 million people at
some point in their lifetime. In 2006, the Combat Methamphetamine
Epidemic Act (CMEA) was enacted in response to an alarming increase
in and widespread conversion of pseudoephedrine (PSE) containing
products into methamphetamine. Among other things, the CMEA requires
retail stores to maintain their inventory of PSE containing products
in a secured location and restricts the amount of PSE products a
store can sell to an individual customer. In response to the ongoing
methamphetamine problem, several local jurisdictions (state, counties
and/or local municipalities) have enacted or propose to enact
legislation to require a physician's prescription to obtain a
PSE-containing product. 
PSE is a widely-used nasal decongestant available in many
non-prescription and prescription cold, sinus and allergy products.
PSE is sold in products as the only active ingredient in both
immediate and extended-release products. In addition, PSE is combined
with other cold, sinus and allergy ingredients such as pain
relievers, cough suppressants and antihistamines. PSE also competes
against phenylephrine, an alternate nasal decongestant available in
non-prescription products. In 2009, AC Nielsen reported approximately
$1.0 billion in sales of non-prescription products containing either
PSE or phenylephrine as a nasal decongestant, of which approximately
47% contained PSE. 
About NEXAFED
 NEXAFED [pseudoephedrine hydrochloride] is a 30 mg
immediate-release abuse-deterrent decongestant. The next generation
pseudoephedrine tablet combines effective nasal congestion relief
with IMPEDE technology, a unique polymer matrix that disrupts the
conversion of pseudoephedrine into the dangerous drug,
methamphetamine. IMPEDE technology forms a thick gel when the tablets
are dissolved in solvents typically used in the pseudoephedrine
extraction or methamphetamine production processes, trapping the
pseudoephedrine or converted methamphetamine to resist its isolation
or purification.  
About Acura Pharmaceuticals
 Acura Pharmaceuticals, Inc. is a
specialty pharmaceutical company dedicated to bringing to market safe
and effective products intended to address medication abuse and
misuse. As a leader in abuse-deterrent technology, Acura has
successfully developed a prescription drug product that addresses
abuse and which is licensed to and marketed by a major pharmaceutical
company. Acura is committed to addressing the needs of local
communities by investing in ongoing research and development to drive
improvement in abuse-deterrent technology. 
Forward Looking Statements
 Certain statements in this press release
constitute "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors which may cause our actual results,
performance or achievements to be materially different from any
future results, performance, or achievements expressed or implied by
such forward-looking statements. Forward-looking statements may
include, but are not limited to, the timing of our ability to
successfully develop and launch our next generation NEXAFED Tablets,
the market acceptance of and competitive environment for any of our
products, the willingness of wholesalers and pharmacies to stock
NEXAFED Tablets, expectations regarding potential market share for
our products and the timing of first sales, the adequacy of the
results of the laboratory and clinical studies completed to date, the
sufficiency of our development to meet over-the-counter, or OTC,
Monograph standards as applicable, adverse safety findings relating
to our product candidates, our exposure to product liability and
other lawsuits in connection with the commercialization of our
products, the increasing cost of insurance and the availability of
product liability insurance coverage, and whether our IMPEDE
technology, including our NEXAFED Tablets, will disrupt the
processing of pseudoephedrine into methamphetamine, including whether
NEXAFED will prove resistant to methamphetamine conversion methods
that may be utilized in the future by clandestine methamphetamine
laboratories. In some cases, you can identify forward-looking
statements by terms such as "may," "will," "should," "could,"
"would," "expects," "plans," "anticipates," "believes," indicated,"
"estimates," "projects," "predicts," "potential" and similar
expressions intended to identify forward-looking statements. These
statements reflect our current views with respect to future events
and are based on assumptions and subject to risks and uncertainties.
Given these uncertainties, you should not place undue reliance on
these forward-looking statements. We discuss many of these risks in
greater detail in our filings with the Securities and Exchange
Commission. 
Contacts
Peter Clemens
Acura Pharmaceuticals
pr@acurapharm.com 
847-705-7709 
Media:
Leticia Diaz
Spectrum
ldiaz@spectrumscience.com 
202-955-6222 
 
 
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